A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial

Not Applicable

• Conditions: Fascial Closure
• Interventions: Procedure: modified component separation technique

• Registration Number: NCT03111134
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. There are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. The key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing.

It's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. But the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia.

Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing.

In this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-CST will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Study First Posted: 2017-04-12
• Last Update Posted: 2017-04-12
• Study Start: 2017-05-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• adult patients >18 years of age
• undergoing gastric cancer surgery
• undergoing abdominal surgery first time
• median upper abdominal incision applied (length of incision > 5cm)
• randomly select abdominal closure technique agreed by patients and family members

Exclusion Criteria

• women who pregnant
• coagulation disorders
• undergoing immunological therapy
• undergoing chemothearphy within 2 weeks before the surgery
• undergoing Abdominal radiotherapy within 8 weeks before the surgery
• spirit disease patients
• the expecting life span less than 48 hours
• no guarantees to follow-up for 3 years
• patients with poor compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Abdominal Closure	modified component separation technique	modified component separation technique is used to abdomen closing.

Primary Outcome Measures

Name	Time	Method
Class A healing rate of the surgical incision	1 month	Class A healing rate of the surgical incision after operation

Secondary Outcome Measures

Name	Time	Method
hospitalization time after operation	1 year	hospitalization time after operation
hospitalization costs	3 years	hospitalization costs for the surgery and its complications
the incidence rate of unplanned second operation	1 month	the incidence rate of unplanned second operation after the surgery
the mortality	1 month	the mortality after the surgery with any reason
the incidence rate of incisional hernia	3 years	the incidence rate of incisional hernia after the surgery
the incidence rate of unplanned readmission	1 month	the incidence rate of unplanned readmission after the surgery
the incidence rate of acute pain	1 month	the incidence rate of acute pain after the surgery
the incidence rate of incisional complications	1 month	the incidence rate of any incisional complications after the surgery
the time of suture to clear	1 month	the time of suture to clear after the surgery

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shanxi, China